CClinicalTrials.gg
TerminatedNCT05246839Updated Nov 10, 2025

Informed Choice - Compass

An observational study in Colorectal Cancer, sponsored by Exact Sciences Corporation. Terminated at 39 sites in United States. Open to participants aged 45 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-10.

Sponsored by Exact Sciences Corporation · Observational

Why this study was terminated
Business decision to terminate the study early. Primary endpoint will not be assessed.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,823
Ages
45 Years to 70 Years
Sex
All
01

Study summary

The primary objective of this study is to evaluate the impact of a theoretically grounded video that includes information about CRC screening modality choices on CRC screening rates and time adherent to CRC guidelines. The results will not be posted because the study terminated early and the primary endpoint was not analyzed.

Read the detailed description

Participants 45 to 70 years of age, scheduled for a primary care (index) appointment, at average risk for colorectal cancer (CRC), and due for CRC screening will be enrolled in the study. Participants will be randomized to one of three intervention arms: no video (arm 1), brief CRC screening video (arm 2), or enhanced CRC screening video (arm 3). Participants in all intervention arms will complete surveys regarding intention to screen for CRC and preference for screening modality prior to viewing the video, after the video, and after their index appointment. Participants will be surveyed, and medical information collected, for 1 year after randomization to assess adherence to CRC screening and CRC screening outcomes.

02

Conditions studied

  • Colorectal Cancer

Keywords

  • CRC Screening
  • Colonoscopy
  • FIT
  • Cologuard
  • Screening Modality
  • Survey
  • Video
  • sDNA-FIT
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's enrollment of 1,823 is above the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Exact Sciences Corporation is the lead sponsor of 31 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Subjects will be 45 to 70 years of age, inclusive, who are scheduled for a primary care appointment, at average risk for colorectal cancer (CRC), and due for CRC screening. The study will enroll approximately 1,851 subjects.

Inclusion criteria

  1. Participant is 45 to 70 years of age, inclusive.
  2. Participant presents for a primary care appointment.
  3. Participant understands the study procedures and can provide informed consent to participate in the study and authorization for release of relevant protected health information (PHI) to the study Investigator.
  4. Participant has never been screened for CRC.

Exclusion criteria

Exclusion Criteria:

  1. Participant has symptoms or signs that require immediate, or near-term referral for diagnostic or therapeutic colonoscopy.
  2. Participant is due for CRC screening within three months and is already scheduled for colonoscopy.
  3. Participant has a personal history of CRC or colonic adenomatous or sessile serrated polyps.
  4. Participant has a personal history of inflammatory bowel disease.
  5. Participant has a family history of CRC in at least one first- or second-degree relative diagnosed prior to age 60 and/or at least 2 first-degree relatives diagnosed with CRC at any age.
  6. Participant has a personal diagnosis or family history of any of the following conditions:

    1. Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner's syndrome),
    2. Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome"),
    3. Other hereditary cancer syndromes including, but are not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Neurofibromatosis, or Familial Hyperplastic Polyposis.
  7. Participant has a diagnosis of Cronkhite-Canada Syndrome.
  8. Participant is current with CRC screening, including gFOBT or FIT within the preceding 12 months, Cologuard within the preceding 3 years, flexible sigmoidoscopy or CT colonography within the preceding 5 years, or colonoscopy within the preceding 10 years. Participants can be enrolled up to 3 months prior to screening due date.
  9. Participant has any condition that in the opinion of the Investigators should preclude participation in the study, including comorbid illnesses precluding endoscopic evaluation or that limit life expectancy to less than 10 years.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,823 participants (actual)
Patient registry
No

Groups and cohorts

  • Arm 1 - Usual Care (No Video)

    Participant will receive the usual care pertaining to colorectal cancer (CRC) screening according to their respective clinical site and will not view either of the study videos.

  • Arm 2 - Brief Video

    Participant will watch a video pertaining to the importance of CRC screening.

    Behavioral: Brief Video

  • Arm 3 - Brief Video Plus

    Participant will watch the same video as described in Arm 2, immediately followed by a second video pertaining to 3 CRC screening modalities: colonoscopy, FIT, and Cologuard.

    Behavioral: Brief Video Plus

Interventions

  • BehavioralBrief Video

    Videos about colorectal cancer screening.

  • BehavioralBrief Video Plus

    Videos about colorectal cancer screening and modalities.

06

What researchers measure

Primary outcomes

  1. Impact of Brief Videos

    To evaluate the impact of a theoretically grounded video that includes information about CRC screening modality choices (colonoscopy, FIT, and Cologuard) on CRC screening rates and the proportion of time adherent to CRC guidelines.

    Time frame: 1 year

Secondary outcomes

  1. Participant Screening Preferences

    To examine initial mode preferences between participants viewing a theoretically grounded video that includes information about CRC screening modality choices (colonoscopy, FIT, and Cologuard) compared to those receiving only a brief informational video about CRC screening or receiving only usual care.

    Time frame: 1 year

Other outcomes

  1. Exploratory Objective- Participant

    Evaluate participant knowledge, attitudes, and intentions related to CRC screening and assess personal and environmental factors associated with screening intentions and completion by modality.

    Time frame: 1 year

  2. Exploratory Objective- Provider

    Characterize provider, system, and site-level factors associated with CRC screening rates and use of various screening modalities at different times throughout the intervention (prior to and after recruitment is completed).

    Time frame: 1 year

07

Study locations

39 sites
  • Absolute Clinical Research
    Phoenix, Arizona 85323, United States
  • Biopharma Informatic
    Los Angeles, California 90035, United States
  • Saviers Medical Group
    Port Hueneme, California 93041, United States
  • Skylight Health Group
    Aurora, Colorado 80012, United States
  • Skylight Health Group
    Jacksonville, Florida 32218, United States
  • I.V.A.M Clinical & Investigational Center
    Miami, Florida 33144, United States
  • ITB Research
    Miami, Florida 33173, United States
  • Emerald Coast OBGYN
    Panama City, Florida 32405, United States
  • ClinCept, LLC
    Columbus, Georgia 31904, United States
  • Pivotal Clinical Research & Associates, LLC
    Marietta, Georgia 30062, United States
  • Herman Clinical Research, LLC
    Suwanee, Georgia 30013, United States
  • Sheridan Medical Center, S.C
    Chicago, Illinois 60613, United States
  • Ascension DePaul Community Services of New Orleans
    New Orleans, Louisiana 70118, United States
  • Annapolis Internal Medicine
    Annapolis, Maryland 21401, United States
  • Advanced Primary and Geriatric Care
    Rockville, Maryland 20850, United States
  • Valley Ob-Gyn Clinic, PC
    Saginaw, Michigan 48602, United States
  • St. Louis Medical Professionals
    St Louis, Missouri 63119, United States
  • Barrett Clinic
    La Vista, Nebraska 68128, United States
  • Alliance Community Healthcare, INC
    Jersey City, New Jersey 07302, United States
  • North Hudson Community Action Corporation
    Union City, New Jersey 07087, United States
  • Ellipsis Research Group, LLC
    Brooklyn, New York 11215, United States
  • Niagara Falls Memorial Medical Center
    Niagara Falls, New York 14304, United States
  • Laurelton Heart Specialist PC
    Rosedale, New York 11422, United States
  • OnSite Clinical Solutions, LLC
    Charlotte, North Carolina 28208, United States
  • Hightower Clinical OKC
    Oklahoma City, Oklahoma 73134, United States
  • Skylight Health
    Harrisburg, Pennsylvania 17109, United States
  • Mercado Medical Practice
    Philadelphia, Pennsylvania 19111, United States
  • Pottstown Medical Specialists Inc
    Pottstown, Pennsylvania 19464, United States
  • Center for Medical Research, LLC
    Providence, Rhode Island 02908, United States
  • Medical University of South Carolina
    Charleston, South Carolina 29425, United States
  • SPICA Clinical Research
    Columbia, South Carolina 29322, United States
  • The Jackson Clinic, PA
    Jackson, Tennessee 38305, United States
  • Clear Brook Medical Associates
    Houston, Texas 77089, United States
  • BioPharma Informatic
    Pharr, Texas 78577, United States
  • Valena Medical Research
    Spring, Texas 77379, United States
  • A & U Family Medicine
    Sugarland, Texas 77479, United States
  • Ogden Clinic - Mountain View
    Pleasant View, Utah 84404, United States
  • Ogden Clinic - Grand View
    Roy, Utah 84067, United States
  • South Ogden Family Medicine
    South Ogden, Utah 84405, United States
08

References and documents

Publications

  • Griffin JM, Finney Rutten LJ, Zhu X, Feng Z, Rogers CR, Marsh TL, Inadomi JM. The COMPASS study: A prospective, randomized, multi-center trial testing the impact of a clinic-based intervention informing patients of colorectal cancer screening options on screening completion. Contemp Clin Trials. 2022 Aug;119:106852. doi: 10.1016/j.cct.2022.106852. Epub 2022 Jul 13. PubMed 35842109 ↗

Individual participant data

Plan to share: Yes — Individual participant data that underlie the results reported in publications of the study may be shared after deidentification. This may include text, tables, figures, and appendices. The study protocol, statistical analysis plan (when applicable), informed consent form (when applicable), and clinical study report (when applicable) may also be shared. Data will be available from 2 years and ending 4 years after publication. Data may be shared with researchers who provide a methodologically sound proposal to achieve the aims outlined in the approved proposal.

Supporting information: Study protocol, Sap, Icf, Csr

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05246839
Lead sponsor
Exact Sciences Corporation
Collaborators
Mayo Clinic, University of Utah, American Cancer Society, Inc., F!ght Colorectal Cancer
Responsible party
Sponsor
First posted
Feb 18, 2022
Start date
Apr 28, 2022
Primary completion
Jan 31, 2025
Completion
Jan 31, 2025
Last update
Nov 10, 2025

Study contacts

Joan M. Griffin, PhD
principal investigator · Mayo Clinic College of Medicine
John Inadomi, MD
principal investigator · University of Utah
Charles R. Rogers, PhD
principal investigator · Rogers Solutions Group

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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